Subject: Xermelo 1670-A SGM P2021

Drug

XERMELO  (telotristat ethyl)

Policy:

I.    INDICATIONS 

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that  all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications
Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. 

All other indications are considered experimental/investigational and not medically necessary.

II.  CRITERIA FOR INITIAL APPROVAL
      Carcinoid syndrome diarrhea                                                                                                     
      Authorization of 3 months may be granted for the treatment of carcinoid syndrome diarrhea when both
      of the following criteria are met:
      A.   The member has had an inadequate response to somatostatin analog (SSA) therapy alone
      B.   Xermelo will be used in combination with SSA therapy

III. CONTINUATION OF THERAPY 

Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication  listed in Section II when all of the following criteria are met:
A.   The member is currently receiving the requested medication through a paid pharmacy or medical benefit
B.   The member is receiving the requested medication in combination with SSA therapy
C.   The member is experiencing benefit from therapy as evidenced by disease stability or disease improvement
      (e.g., reduction in the number of daily bowel movements).

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xermelo [package insert]. Deerfield, IL: TerSera Therapeutics LLC; October 2020.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 20, 2022